FDA Product Code
FDA Product Code IME — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Physical Medicine
- 21 CFR Citation
- 890.5700
510(k) Clearances — 27 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K923627 | COLD PACK | Friendmed Products | 1993-04-14 | Traditional | PDF ↗ |
| K915876 | HOTPAD | Ten Comfort Corp. | 1993-02-12 | Traditional | PDF ↗ |
| K921446 | HOT OR COLD PACK (THERMIPAQ) | Thermionics Corp. | 1992-07-13 | Traditional | PDF ↗ |
| K905207 | MICRO-AIRE SOFT-ICE, COLD THERAPY COMPRESS | Micro Surgical Instruments Corp. | 1991-01-22 | Traditional | PDF ↗ |
| K882413 | SUBOCCIPITAL ICE PILLOW | Ferguson Medical | 1988-11-30 | Traditional | PDF ↗ |
| K863654 | RE-HEATER, HOT PACK | K & L Ent. | 1986-10-23 | Traditional | PDF ↗ |
| K832193 | NICE PACK | Universal Medical Instrument Corp. | 1983-08-31 | Traditional | PDF ↗ |
| K831899 | ENSWELL | Dr. Micheal A. Sabia | 1983-07-07 | Traditional | PDF ↗ |
| K830981 | MICROPAK MOIST HEAT PAD | Micropak Manufacturers, Inc. | 1983-06-03 | Traditional | PDF ↗ |
| K830416 | ICY COLD ICE CAP | Ladora Ent. | 1983-03-10 | Traditional | PDF ↗ |
| K823649 | THERMOELASTOMER HOT/COLD COMPRESS BK7186 | Fred Sammons, Inc. | 1983-01-21 | Traditional | PDF ↗ |
| K823650 | THERMOELASTOMER HOT/COLD COMPRESS-7187- | Fred Sammons, Inc. | 1983-01-21 | Traditional | PDF ↗ |
| K823814 | HOT/COLD PACK HOLDERS | Danek Medical, Inc. | 1983-01-14 | Traditional | PDF ↗ |
| K822783 | FLEX ICE FREEZE PACK | Igloo Corp. | 1982-10-06 | Traditional | PDF ↗ |
| K821636 | ATTACH-A-PAK | Fred Sammons, Inc. | 1982-06-11 | Traditional | PDF ↗ |
| K820901 | COLD ROLL | North Bank Labs, Inc. | 1982-04-15 | Traditional | PDF ↗ |
| K820068 | COLD-HOT PACK | Hospital Marketing Services Co., Inc. | 1982-01-28 | Traditional | PDF ↗ |
| K810402 | ACE COLD BANDAGE | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1981-03-04 | Traditional | PDF ↗ |
| K810451 | REUSEABLE HOT & COLD PACKS | Fred Sammons, Inc. | 1981-03-04 | Traditional | PDF ↗ |
| K803299 | COLD/HOT PACK | W.G. Whitney Corp. | 1981-01-15 | Traditional | PDF ↗ |
| K801365 | KOLD WRAP | Romaine, Inc. | 1980-08-07 | Traditional | PDF ↗ |
| K801776 | COLD PACK #589 | Sunbeam Corp. | 1980-08-07 | Traditional | PDF ↗ |
| K800917 | TRU-COLD THERAPY PAK | Tru-Eze Mfg. Co., Inc. | 1980-05-02 | Traditional | PDF ↗ |
| K792182 | ICE CONTAINER I.C.E. | Delta Medical Industries | 1979-11-15 | Traditional | PDF ↗ |
| K791684 | WARM-EE HEAT PACK | U.S. Export Marketing Group, Inc. | 1979-10-30 | Traditional | PDF ↗ |
| K790009 | ICE PACK, REUSABLE FLEXIBLE | Ackrad Laboratories | 1979-01-22 | Traditional | PDF ↗ |
| K771002 | ICE BAND | Norcliff Thayer, Inc. | 1977-08-30 | Traditional | PDF ↗ |
Product code IME · Class I · Physical Medicine. Data: openFDA.